Disposable human blood dialysis device

ABSTRACT

A dialysis device for handling human blood in an artificial kidney system using an improved interleaved, wrapped arrangement of the tubular blood-filtering membrane and its supporting mesh which cooperate to provide the filtering body thereof, wherein the membrane inlet and outlet are confined against rupturing movement and the helical wrap of the membrane is supported by the mesh without a severe change in direction, thereby minimizing the introduction of a flow resistance force that can not be readily controlled.

United States- Patent [191 Zimmerman DISPOSABLE HUMAN BLOOD DIALYSIS DEVICE Inventor: Lester Zimmerman, l-licksville, N.Y.

Vernitron Medical Products, Inc., Great Neck, NY.

Filed: Mar. 11, 1971 Appl. No.: 123,232

Assignee:

US. Cl. 210/321, 210/494 lnt. CL; B0ld 31/00 Field of Search 210/22, 321, 494

References Cited UNITED STATES PATENTS 4/1970 Miller .l 210/494 X 3/1972 Versaci 210/321 X June 26, 1973 3,077,268 2/1963 Gobel et al. 2l0/494 X Primary ExaminerFrank A. Spear, Jr. Attorney-Edward l-l. Loveman, Esq.

[57] ABSTRACT A dialysis device for handling human blood in an artificial kidney system using an improved interleaved, wrapped arrangement of the tubular blood-filtering membrane and its supporting mesh which cooperate to provide the filtering body thereof, wherein the membrane inlet and outlet are confined against rupturing movement and the helical wrap of the membrane is supported by the mesh without a severe change in direction, thereby minimizing the introduction of a flow resistance force that can not be readily controlled.

7 Claims, 5 Drawing Figures DISPOSABLE HUMAN BLOOD DIALYSIS DEVICE The present invention relates generally to devices for dialysis or ultrafiltration, and specifically to an improved dialysis device for human blood purification in an artificial kidney system.

The dialysis device hereof is of the type used in artificial kidney systems wherein the fluid contents of human blood are separated by a permeable membrane, some of these fluid contents consisting of exogenous or endogenous poisons, or the like, passing through the membrane and being flushed away by a dialyzing fluid. The actual filtering construction or body thereof, consisting of an interleaved, wrapped arrangement of the membrane, in tubular form, and of its supporting mesh, is already well known according to U. S. Pat. No. 3,508,662 issued on Apr. 28, 1970 and other prior patents cited therein. While this general construction in a filtering body is generally satisfactory for use in a dialysis device, it has the serious-shortcoming, at least as used in the mentioned patents, of requiring a severe directional change in the helically wrapped tubular membrane. This, in turn, imposes a restrictive force on the blood flow through the membrance which is not of a precisely known extent or magnitude and which is, therefore, not readily subject to control,

Broadly, it is an object of the present invention to provide an improved artificial kidneysystem dialysis device overcoming the foregoing and other shortcomings of the prior art. Specifically, it is an object to provide a filtering body construction for a human blood dialysis device having a uniform, predictable flow resistance characteristic, due primarily to the avoidance of severe changes in direction in the helically wrapped tubular membrane. I

A filtering body for a human blood dialysis device demonstrating objects and advantages of the present invention'includes, as a noteworthy structural addition to the known helically wrapped arrangement of membrane and supporting mesh, the use of a mounting cavity for the membrane outlet advantageously located adjacent the body outer wrap, said cavity being bounded by walls extending inwardly of the body to a prescribed depth. Thus, the outflowing blood merely proceeds generally in a continuous, uninterrupted fashion, rather than being forced through the prior art arrangement of the membrane in which it is threaded back through the body so it can be supported on a rigid inner core of the body.

The above brief description, as well as further objects, features and advantages of the present invention, will be more fully appreciated by reference to the following detailed description of a presently preferred, but nonetheless illustrative embodiment in accordance with the present invention, when taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a simplified diagramatic view of an exemplary artificial kidney system including the improved disposable filtering device hereof;

FIG. 2 is an isolated side elevational view of the filtering device, on an enlarged scale and in section to better illustrate internal structural features thereof;

FIG. 3 is a partial perspective view of the filtering body of the filtering device hereof illustrating the recessed cavity for accommodating the outlet fluid connection thereof;

FIG. 4 is an isolated side elevational view of the outlet fluid connection hereof, which is in section to better illustrate structural features thereof; and

FIG. 5 is a perspective view of the filtering body in which the outer wrap of the supporting mesh thereof is shown removed from the body proper in order to illustrate the manner in which the outlet fluid connection is supported within an accommodating recessed cavity formed in said filtering body.

Reference is now made to the drawings and in particular to FIG. 1 illustrating an exemplary artificial kidney system, generally designated 10. It will be understood that system 10 is of the type utilized for human blood dialysis or ultrafiltration and, to this end, includes an inlet conduit 12 having a fluid communication via an appropriate connection to the patients artery for the purpose of passing the patients blood through the dialysis or filtering device hereof, generally designated 14. Specifically, a so-called finger or other such appropriate pump 16 powered by an electric motor 18 is operatively arranged in the inlet conduit 12 so as to force theblood through the dialysis device 14 preparatory to the removal therefrom of exogenous or endogenous poisons. The purified or processed blood is then returned via the return or outlet conduit 20 to the circulatory system of the patient, passing in the process through the collection chamber 22 to exhaust any entrapped bubbles from the processed blood.

As is generally understood, the dialysis or ultrafiltration process which occurs'within the dialysis device 14 contemplates the flowing of the human blood, which has been removed from the patient, through a permeable membrane wherein the previously noted poisonous fluid contents thereof flows through the membrane and is carried away by a dialyzing fluid passing in flushing relation with the'permeable membrane, all as will be explained subsequently herein. It is convenient at this point to note that the dialyzing fluid is recirculated between a source of supply in a sump 24 and the dialysis device 14 by a pump 26 operated by a motor 28 via the conduit connections 30 and 32.

What has been described thus far is well known in the prior art. In fact, the filtering body, as shown in FIGS. 2, 3 and 5 is also of a generally well'known type, although it should be understood that it includes, in addition, structural features which are not known and which constitutes a patentable advance over what is known. The aspects of the device 14 which are known are its general construction which will now be described. This consistsv of an inner rigid plastic core 34 which supports and has in wrapped relation about it a filtering body, generally designated 36, which is formed as a helically wrapped, interleaved arrangement of a supporting mesh 38 (see in particular FIG. 5) and an elongated tubular blood-filtering membrane 40 having an operative supported position, as illustrated in FIG. 2, on the rigid support core 34. The tubular membrane 40 is readily available and, in a well understood manner, functions during operation of the dialysis device 14 to separate that portion of the fluid contents of the human blood consisting of exogenous or endogenous poisons. Specifically, as generally understood, the blood is forced through the helical turns of the elongated tubular membrane 40 during which only the poisonous fluid contents thereof are capable of and thereby pass through its permeable walls. The dialyzing or flushing fluid, which may consist of water, is pumped l through the previously noted inlet 32- against the bottorn surface of the unit 14;Asbest shown in FIG; 1, the

dialyzing fluid 2 4 initially strikes a closure 42 inthe bottom opening of the support core 341 and is ;consequently displaced to either side ofthis closureyand is f prevented from bypassingthe filtering body 36 byfa between the helical wraps of the support mesh 38and sealing ring 44 on which theflltering body 36 is firmly f seated. Thus, the dialyzing fluid 24 is forced along the flow path designated 46 in FlG. 1 through the spaces thus in flushingrelationwith the tubularcrriembrane 40 which is interleavedbetween the wraps of supporting i" mesh 38. In this manner, thepoisonsthat are passed through the permeable walls of the tubularybloodfiltering membrane 40 are carried to a remote location in accordance with well known techniques in the operation of the artificial kidneysystem 10.

During the foregoing process, a known amount of external pressure is applied against the tubular blood-y filtering membrane 40 by any one of several techniques in order to introduce a known resistance force to blood let conduitZll, extends from the upper endof cavity60.

lln practice, as illustratedinvFlG. 5, theoutlet fluid con l ,nection 56 ,ofithe tubulargrnembranel4 'isthusableto be fixedly located adjacentthe duterlwrapof the filter-1;

ingjbody 36, rather than being required tdiindrgola'se- .yere directional change as wou ldhbe required if itfhad to be extended fr oml the outer wrap back to theinnjer frigid core 34for mounting on the rigid core 34.

From theforegoing, itlshould bereadily appreciated that in additionto avoidanceof any severe directional change in the tubular'mernbi ane that the1useof the I cavity'60 in the advantageous locatlonyin thefilte'ringj,

body 36asjnst described also results instructurewhich againstfthe membrane 40 by the dialyzing fluid passing,

in flushingcontact with it, could resultin a rupturing flowing through the tubular membrane 40. The applied force has significanteffecton the dialyzing capability of the tubular membrane 40; In the illustrated example hereof, this external force 48, which as clearly illus- 52 of a select diameter which provides the extent of ex Reference is now made trated in FIG. 2 is applied circumferentially upon the filtering body 36, is achieved by forceflttingthe filter ingbody 36, consisting of a select number ofhelical turns'of supporting mesh, within retaining rings and ternal'pressure 48 which is desired. Alternatively, the

filtering body 36 can be disposed within and thereby subjected to any select amount of pressure applied by an inflatable cuff. T

In accordance with thepresent invention,severe changes in direction of the elongated tubular membrane 40 are minimized since these changes indirection introduce resistance to flow through the mem brane which are not subject to accurate control. 'lhe avoidance of these severe changes in direction is achieved as follows. The tubular membrane 40, as best which is connected via afluid connection, generally designated 56, to the previously noted inletconduit'12.

of the filtering body 36 should be noted whichcontributes to the avoidance of severe directional changes in let fluid connection 56. Cavity is advantageously 10- cated adjacent the upperend 62 of the filtering body illustrated in FIG. 2, has at one end a length portion I bounding an inlet opening,'generally designated 54,,

4 At its opposite end, the tubular membrane 40 termi- Q the outersleeve 84on the'inner plug 74 while maintain- *ing the length ofthe tubular membrane40 bounding.

vthe outlet opening 58 in its interposed positionbetween I l the inner plug 74 and outer sleeve 84.Additionally,'the smaller open end88 of sleeve 84 will be understood to be sized sothat it is slightly smaller than radial ridge 78 adjacent one end of the in'ner plug 74 to an extent of the membrane andthusloss of human blood flowing;

through the membrane.

fluid connection 56 includesan inner plug preferrebly cylindrical in cross s ection, having an inner through bore 76 sized to accommodate in a force fit anjenjd of H the outlet eonduit 20. Theoutercylindrical surface of the plug74 is appropriately machined or moldedlwith I r a series of three alternate radial projections 7&80 and concentricgrooves 82. Completing each fluid connec f r tion 56 is an outer conical sleeve 84 having an inner diameter of an appropriate size providing a forcefit of the sleeve 84 upon the inner plug 74. Sleeve;8 4 also 3 preferrably'hasa radial flange 86 which, as part of the outlet connectionfhelps seat this connectionon the flat I side wall 68and, as part or the inlet connection, seats a h in thecounterbore 72 to effectively hold the inlet cons i nection in mountingp ositionon the rigid inner core 34.

The'assembly of the outlet fluid connection56 to the tubular membrane 40 includes disposing the inner plug 74 within the outletopening 58 and then forcetitting where the end opening 88 thereof slips over and then snaps behind the projection or ridge 78. This, in an ob serve, in an obvious manner, as fluid seals preventing 36 and consists of converging curved side walls 64 and 66 which extend from the outer wrap inwardly of the filtering body 36 in the direction of the rigid core 34, and a third cooperating substantiallyflat side wall68 which functions as a seat forthe outlet fluid connection 56. A smaller cavity 70, sized to accommodate the outvious manner, contributesto holding sleeve 84in position about the plug The outer ridges79 and 80 any leakage of the human blood between the sealing U members 74 and 84.1

A latitude of modificatiomchange and substitution is intended in the foregoinghdisclosure, and in some in; stances somefeaturesof the invention will be employed without a corresponding use of other features. Accordl to FIG. 4 inwhich there is I L shown, on an enlarged scale to better illustrate the structural features, the outlet fluid connectionf56.iAs noted, this fluidconnection'is similar in construction to the inlet fluidconnection 56 and therefore the description of one such fluidconnection, as illustrated in FIG. 4, will suffice for the purpose of conveying a complete Y understanding ofthe present invention. The illustrated e ingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the spirit and scope of the invention herein.

I claim:

1. A human blood filtering device comprising a support core, a filtering body formed as a helically wrapped, interleaved arrangement of a supporting mesh and of an elongated tubular blood-filtering membrane having an operative supported position on said support core, said tubular blood-filtering membrane having an inlet opening adjacent the innermost wrap of said filtering body, a blood inlet conduit means having a fluid connection to said membrane inlet opening and operatively fixedly mounted on said support core to minimize any rupturing movement in said fluid connection, a blood outlet conduit means having a fluid connection to said membrane outlet opening, and means to restrain said last named fluid connection against any rupturing movement consisting of a recessed cavity formed in said filtering body, said cavity being bounded by plural walls extending inwardly from said filtering body outermost wrap to a prescribed depth in the direction of said support core, whereby there is an optimum minimum restriction to blood flow, through said blood-filtering membrane due to changes in flow direction therethrough.

2. A human blood filtering device as claimed in claim 1 wherein each said fluid connection comprises an inner plug member having an operative position force fit within an outer sleeve member, and the portion of said blood-filtering membrane bounding said outlet and inlet openings thereof in sealed position interposed between said inner plug and said outer sleeve.

3. A human blood-filtering device as claimed in claim 2 wherein said inner plug is cylindrical in cross section and has plural concentric ridges spaced between the ends thereof, said ridge adjacent one said end serving as a seat for holding said outer sleeve member in position and said other ridges serving as fluid seals.

4. A human blood filtering device comprising a support core, a filtering body formed in a cylindrical shape with opposite first and second operative ends of a helically wrapped, interleaved arrangement of a supporting mesh and of an elongated tubular blood-filtering membrane having an operative supported position on said support mesh and of an elongated tubular bloodfiltering membrane having an operative supported position on said support core, said tubular blood-filtering membrane having an inlet opening located adjacent said filtering body first operative end and also adjacent said support core and an outlet opening located adjacent said filtering body second operative end and also adjacent the outermost wrap of said filtering body, a blood inlet conduit means having a fluid connection to said membrane inlet opening and operatively fixedly mounted on said support core to minimize any rupturing movement in said fluid connection, a blood outlet conduit means having a fluid connection to said membrane outlet opening, and means to restrain said last named fluid connection against any rupturing movement consisting of a recessed cavity formed in said filtering body adjacent said second operative end thereof, said cavity being bounded by plural walls extending inwardly from said filtering body outermost wrap to a prescribed depth in the direction of said support core,

whereby there is an optimum minimum restriction to blood flow through said blood-filtering membrane due to changes in flow direction therethrough.

5. A human blood-filtering device as claimed in claim 4 wherein the helical turns of said blood-filtering membrane are located adjacent said filtering body first operative end except for the last helical turn thereof which contains said outlet opening, said last helical turn being threaded from said filtering body first operative end to said second operative end thereof.

6. A human blood-filtering device as claimed in claim 4 wherein each said fluid connection comprises an inner plug member having an operative position force fit within an outer sleeve member, and the portion interposed between said inner plug and said outer sleeve.

7. A human blood-filtering device as claimed in claim 6 wherein said inner plug is cylindrical in cross section and has plural concentric ridges spaced between the ends thereof, said ridge adjacent one said end serving as a seat for holding said outer sleeve member in position and said other ridges serving as fluid seals. 

1. A human blood filtering device comprising a support core, a filtering body formed as a helically wrapped, interleaved arrangement of a supporting mesh and of an elongated tubular blood-filtering membrane having an operative supported position on said support core, said tubular blood-filtering membrane having an inlet opening adjacent the innermost wrap of said filtering body, a blood inlet conduit means having a fluid connection to said membrane inlet opening and operatively fixedly mounted on said support core to minimize any rupturing movement in said fluid connection, a blood outlet conduit means having a fluid connection to said membrane outlet opening, and means to restrain said last named fluid connection against any rupturing movement consisting of a recessed cavity Formed in said filtering body, said cavity being bounded by plural walls extending inwardly from said filtering body outermost wrap to a prescribed depth in the direction of said support core, whereby there is an optimum minimum restriction to blood flow through said bloodfiltering membrane due to changes in flow direction therethrough.
 2. A human blood filtering device as claimed in claim 1 wherein each said fluid connection comprises an inner plug member having an operative position force fit within an outer sleeve member, and the portion of said blood-filtering membrane bounding said outlet and inlet openings thereof in sealed position interposed between said inner plug and said outer sleeve.
 3. A human blood-filtering device as claimed in claim 2 wherein said inner plug is cylindrical in cross section and has plural concentric ridges spaced between the ends thereof, said ridge adjacent one said end serving as a seat for holding said outer sleeve member in position and said other ridges serving as fluid seals.
 4. A human blood filtering device comprising a support core, a filtering body formed in a cylindrical shape with opposite first and second operative ends of a helically wrapped, interleaved arrangement of a supporting mesh and of an elongated tubular blood-filtering membrane having an operative supported position on said support mesh and of an elongated tubular blood-filtering membrane having an operative supported position on said support core, said tubular blood-filtering membrane having an inlet opening located adjacent said filtering body first operative end and also adjacent said support core and an outlet opening located adjacent said filtering body second operative end and also adjacent the outermost wrap of said filtering body, a blood inlet conduit means having a fluid connection to said membrane inlet opening and operatively fixedly mounted on said support core to minimize any rupturing movement in said fluid connection, a blood outlet conduit means having a fluid connection to said membrane outlet opening, and means to restrain said last named fluid connection against any rupturing movement consisting of a recessed cavity formed in said filtering body adjacent said second operative end thereof, said cavity being bounded by plural walls extending inwardly from said filtering body outermost wrap to a prescribed depth in the direction of said support core, whereby there is an optimum minimum restriction to blood flow through said blood-filtering membrane due to changes in flow direction therethrough.
 5. A human blood-filtering device as claimed in claim 4 wherein the helical turns of said blood-filtering membrane are located adjacent said filtering body first operative end except for the last helical turn thereof which contains said outlet opening, said last helical turn being threaded from said filtering body first operative end to said second operative end thereof.
 6. A human blood-filtering device as claimed in claim 4 wherein each said fluid connection comprises an inner plug member having an operative position force fit within an outer sleeve member, and the portion interposed between said inner plug and said outer sleeve.
 7. A human blood-filtering device as claimed in claim 6 wherein said inner plug is cylindrical in cross section and has plural concentric ridges spaced between the ends thereof, said ridge adjacent one said end serving as a seat for holding said outer sleeve member in position and said other ridges serving as fluid seals. 